LIFE-L: Lifestyle Intervention of Food and Exercise for Lymphoma Survivors

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05839210
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate if a mediterranean diet and exercise program for Lymphoma patients during chemotherapy can improve treatment completion and reduce treatment-related side effects.

Condition or Disease	Intervention/Treatment	Phase
Non Hodgkin Lymphoma; Hodgkin Lymphoma	Behavioral: LIFE-L Mediterranean Diet; Behavioral: LIFE-L Home-Based Exercise Program; Behavioral: Supportive Materials	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Lifestyle Intervention of Food and Exercise for Lymphoma Survivors (LIFE - L)
• Anticipated Study Start Date: May 31, 2023
• Anticipated Primary Completion Date: May 31, 2025
• Anticipated Study Completion Date: May 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LIFE-L Group Participants already undergoing chemotherapy treatment as per standard of care for 6 cycles will meet weekly via phone for 30-45 minutes with a health coach that will provide education on a Mediterranean diet and an exercise program.	Behavioral: LIFE-L Mediterranean Diet; Mediterranean Diet will include goals of: 4+ vegetable servings (2-4 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week. Limit or avoid highly processed foods, sugar-sweetened beverages and foods, processed meats, red meat, and alcohol.; Behavioral: LIFE-L Home-Based Exercise Program; The Home-Based Exercise Program will include goals of: 150+ minutes moderate or 75+ minutes vigorous exercise per week, completed in sessions of at least 10-minute duration, including daily aerobic exercise plus two resistance-based exercise sessions per week.; Behavioral: Supportive Materials; Participants will receive an informational study notebook, an exercise reference poster and videos, a Fitbit, and three stretch bands of different intensities. Participants will also receive supportive and informational text messages or emails three (3) times per week during the study; participants can opt-out of these messages. Participants will be requested to utilize the Fitbit app to track exercise sessions, as well as the MyFitnessPal app to track their diet. Support to set up apps will be provided by research staff. For participants who choose not to use the app, a laminated diet and exercise tracking sheet with dry erase marker will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to research staff each week.
Other: Control Group Participants in this group already undergoing 6 cycles of chemotherapy will receive study materials and two 30-45 minutes health coaching sessions four weeks post- intervention.	Behavioral: Supportive Materials; Participants will receive an informational study notebook, an exercise reference poster and videos, a Fitbit, and three stretch bands of different intensities. Participants will also receive supportive and informational text messages or emails three (3) times per week during the study; participants can opt-out of these messages. Participants will be requested to utilize the Fitbit app to track exercise sessions, as well as the MyFitnessPal app to track their diet. Support to set up apps will be provided by research staff. For participants who choose not to use the app, a laminated diet and exercise tracking sheet with dry erase marker will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to research staff each week.

Outcome Measures

Primary Outcome Measures

1. Percentage of Survivors who participate [Up to 12 months]

   Percentage of survivors who agree to participate out of the total number of participants recruited will be assessed using a threshold of greater than or equal to (>=) 50-percent.

2. Percentage of Participants Completing Intervention Sessions [Up to 26 weeks (Post-Intervention)]

   Percentage of intervention session completion at the end of treatment will be assessed, using a threshold of greater than or equal to (>=) 80-percent.

3. Change in percentage of participant satisfaction [4 weeks (post-intervention), up to 30 weeks]

   The change in percentage of participant satisfaction rate at the end of study participation will be assessed, using a threshold of greater than or equal to (>=) 80-percent. Participant satisfaction will be assessed via exit interviews.

Secondary Outcome Measures

1. Average Relative Dose Intensity (RDI) [Up to 30 weeks]

   RDI will be assessed using a threshold of greater than or equal to (>=) 80-percent.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18 years of age or older

2. Any sex/gender

3. Able to provide consent

4. Able to read or understand English or Spanish

5. Diagnosis of untreated Non-Hodgkin or Hodgkin lymphoma, requiring 6 cycles of chemotherapy, being treated with one of the following therapies at discretion of PIs:

6. R-CHOP; Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) or R-CHOP-like regimen

7. Bendamustine and Rituximab (BR)

8. Brentuximab Vedotin, Doxorubicin, Vinblastine, and Dacarbazine (BV-AVD) or Doxorubicin, Bleomycin, Vinblastine, And Dacarbazine (ABVD) or checkpoint inhibitor+ Doxorubicin, Vinblastine, and Dacarbazine (AVD).

9. Approval from treating oncologist, confirmed via email or in writing

10. Delivery of chemotherapy treatments at one of the following institutions:

11. Sylvester Comprehensive Cancer Center

12. University of Miami Hospital/University of Miami Health Systems (UHealth) Tower

13. Internet access on a smart phone, tablet, or computer

14. Willing to be randomized to a Mediterranean diet/home-based physical activity intervention or waitlist-control group.

Exclusion Criteria:

1. Individuals younger than 18 years of age

2. Unable to provide consent

3. Unable to read or understand English or Spanish

4. Any contraindication for diet change or exercising as determined by physician

5. Currently following a vegan or ketogenic diet for the prior month

6. Engaging in >150 minutes of moderate to vigorous physical activity on average per week for the prior month

7. History of dementia or major psychiatric disease

8. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Tracy E Crane, Phd, RDN, University of Miami
• Principal Investigator: Craig Moskowitz, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tracy E Crane, PhD, RDN, Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT05839210
• Other Study ID Numbers: 20221298
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Tracy E Crane, PhD, RDN, Associate Professor, University of Miami: Mediterranean Diet; Exercise Program
• Additional relevant MeSH terms: Lymphoma

Study Results

No Results Posted as of May 3, 2023